MAUDE Adverse Event Report: BECKMAN COULTER COULTER® ACT DIFF 12? ANALYZER; COUNTER, DIFFERENTIAL CELL

Model Number NOT APPLICABLE

Device Problems Fluid/Blood Leak (1250); Infusion or Flow Problem (2964)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/08/2014

Event Type  malfunction  

Event Description

The customer reported the baths were overflowing in the coulter act diff 12 analyzer and the probe was dripping a few mls of fluid.The leak was not contained.There was no biohazard exposure to open wounds or mucous membranes.No erroneous results were generated.

Manufacturer Narrative

The fse confirmed the leak from the probe and baths were due to excessive back pressure from the diluent prime lines.The fse replaced lv10, micron filters, and the peristaltic pump tubing resolving the probe drip and bath overflow.(b)(4).

• Brand Name: COULTER® ACT DIFF 12? ANALYZER
• Type of Device: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER; 11800 sw 147th avenue; miami FL 33196
• Manufacturer Contact: dung nguyen ; 250 s. kraemer blvd.; brea, CA 92821 ; 7149614941
• MDR Report Key: 3592410
• MDR Text Key: 15116616
• Report Number: 1061932-2014-00188
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K973634
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: 6706366
• Device Lot Number: NOT APPLICABLE
• Other Device ID Number: SOFTWARE VERSION: 2.00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1